Bacterial Vaginosis
Conditions
Brief summary
The investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis
Detailed description
Studies have shown that oral Probiotics(Umeta-mimi) can significantly promote the recovery of vaginal flora mainly because intestinal microbiota can migrate and affect vaginal microecology. This project aims to evaluate the efficacy of oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis (BV) and to explore the correlation between vaginal flora and fecal flora by detecting the metagenomics of vaginal secretions and intestinal feces at the time of baseline phase,14 days after treatment， the first month after treatment, 5-7 days after third menstruation after treatment and 5-7 days after sixth menstruation after treatment
Interventions
DRUGMetronidazole vaginal suppositories
Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )
DRUGMetronidazole vaginal suppositories and Probiotics(Umeta-mimi)
Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) and Oral pobiotics(Umeta-mimi,5×109cfu per day,30 days）
Sponsors
BGI, China
Peking University Shenzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18 to 55 years old, with history of sexual activity, 2. Amsel criterion for diagnosing BV 3. Sign informed consent
Exclusion criteria
1. History of systemic organic diseases or psychiatric diseases 2. Planning for or during pregnancy, lactation, menstruation 3. within 5 days of onset of the disease, any antibiotics has been used 4. Long-term use of contraceptives or immunosuppressant 5. Anaphylactic constitution or allergic to known ingredients of research drugs 6. No same fixed partner (RSP) before and after treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate of BV | 14 days after treatment | Assessments with different Units of Measure:clinical symptoms such as itching or burning; fishy smell; homogeneous thin vaginal discharge;Nugent score; pH\>4.5; clue cell. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of BV | The first month after treatment | Nugent score |
Countries
China
Contacts
Primary ContactShangrong Fan, M.D.
Backup ContactYiheng Liang, M.D.
Outcome results
None listed